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Other Treatments Global Adoption
Proxalutamide COVID-19 studies. Recently added: Cadegiani Kintor. Proxalutamide has been officially adopted for early treatment in 1 country. Submit updates/corrections.
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Dec 27
Early Kintor, News Releease (News)
Kintor Pharma Provides Update on One of its Three Multi-Regional Phase 3 Trials of Proxalutamide for COVID-19
Details   News release reporting on interim analysis of NCT04870606, showing that statistical criteria were not met, there was a very low event rate, and that Kintor plans to amend the protocol and continue to enroll higher risk patients.
Dec 25
Late Cadegiani et al., Cureus, doi:10.7759/cureus.20691 (Peer Reviewed)
death, ↓78.0%, p<0.0001
Final Results of a Randomized, Placebo-Controlled, Two-Arm, Parallel Clinical Trial of Proxalutamide for Hospitalized COVID-19 Patients: A Multiregional, Joint Analysis of the Proxa-Rescue AndroCoV Trial
Details   RCT 778 hospitalized patients in Brazil, 423 treated with proxalutamide, showing significantly lower mortality and improved recovery with treatment. NCT04728802 and NCT05126628. Authors note that cases in this trial were predominantly the..
Dec 17
News Kintor, News Comments (News)
Details   News report noting that real-world results for proxalutamide in Paraguay show signfiicantly lower mortality and are consistent with the results of previous studies in Brazil.
Jul 25
Early Cadegiani et al., medRxiv, doi:10.1101/2021.07.24.21261047 (Preprint) Proxalutamide Improves Inflammatory, Immunologic, and Thrombogenic Markers in Mild-to-Moderate COVID-19 Males and Females: an Exploratory Analysis of a Randomized, Double-Blinded, Placebo-Controlled Trial Early Antiandrogen Therapy (EAT) with Proxalutamide (The EAT-Proxa Biochemical AndroCoV-Trial)
Details   Analysis of data from two proxalutamide early treatment RCTs with 445 patients showing substantial improvements in immunologic, inflammatory, thrombotic, and oxygen markers, which may support the observed reduction in hospitalization.
Jul 16
News Kintor Pharmaceutical News Release (News)
Kintor Pharmaceutical Receives Emergency Use Authorization for Proxalutamide for the Treatment of COVID-19 in Paraguay
Details   News release announcing that proxalutamide has been granted an emergency use authorization for COVID-19 in Paraguay.
Jul 10
Early Cadegiani et al., medRxiv, doi:10.1101/2021.07.06.21260086 (Preprint)
death, ↓63.4%, p=1.00
Proxalutamide (GT0918) Reduces the Rate of Hospitalization in mild-to-moderate COVID-19 Female Patients: A Randomized Double-Blinded Placebo-Controlled Two-Arm Parallel Trial
Details   RCT 177 women in Brazil, 75 treated with proxalutamide, showing significantly lower hospitalization with treatment.
Jul 2
Late Zimerman et al., medRxiv, doi:10.1101/2021.06.28.21259661 (Preprint) Proxalutamide (GT0918) Reduction of Mortality Rate in Hospitalized COVID-19 Patients Depends on Treatment Duration - an Exploratory Analysis of the Proxa-Rescue AndroCoV Trial
Details   Analysis of treatment duration in the Proxa-Rescue AndroCoV trial showing significantly higher mortality among patients that interrupted treatment with proxalutamide. NCT04728802.
Jul 1
Late Medeiros et al., ResearchGate (Preprint) Proxalutamide (GT0918) Improves Lung Injury in Hospitalized COVID-19 Patients -an Analysis of the Radiological Findings of the Proxa-Rescue AndroCoV Trial
Details   Analysis of radiological findings from the Proxa-Rescue AndroCoV trial showing that proxalutamide significantly improves lung opacities compared to placebo. NCT04728802.
Feb 22
Early Cadegiani et al., Cureus, doi:10.7759/cureus.13492 (Peer Reviewed)
viral+, ↓92.1%, p<0.0001
Proxalutamide Significantly Accelerates Viral Clearance and Reduces Time to Clinical Remission in Patients with Mild to Moderate COVID-19: Results from a Randomized, Double-Blinded, Placebo-Controlled Trial
Details   RCT 234 mild-moderate COVID-19 patients with 171 treated with proxalutamide, showing significantly faster viral clearance and recovery. Third party analysis suggests potential randomization failure: [1].
Dec 30
Early McCoy et al., Frontiers in Medicine, doi:10.3389/fmed.2021.668698 (preprint 12/30/2020) (Peer Reviewed)
death, ↓80.0%, p=0.50
Proxalutamide (GT0918) Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial
Details   RCT 268 male patients in Brazil, 134 treated with proxalutamide, showing significantly lower hospitalization and mechanical ventilation. NCT04446429. Expression of concern: [1].
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